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Rīgas Tehniskā universitāte 16.01.2023 11:57
RTU Course "Drug Dosage Forms"
14A24 Department of Chemical Technology of Biologically Active Compounds
General data
Code ĶOS483
Course title Drug Dosage Forms
Course status in the programme Compulsory/Courses of Limited Choice; Courses of Free Choice
Responsible instructor Inese Mieriņa
Academic staff Māra Jure
Volume of the course: parts and credits points 1 part, 2.0 Credit Points, 3.0 ECTS credits
Language of instruction LV, EN
Annotation The study course provides students with in-depth knowledge of the basic rules of industrial
production of pharmaceutical dosage forms and good manufacturing practice, the characteristics of
different drug dosage forms and the basic principles of development/production processes, quality
assessment of drug dosage forms, biopharmaceuticals. The study course examines the interaction
between drugs and food, active substances and excipients. Students are given an insight into the
most important drug dosage forms: hard dosage forms (powders, granules, tablets), aerosols, soft
(ointments, creams, gels, rectal dosage forms, patches) and parenteral dosage forms, dispersed
systems (suspensions, emulsions), gelatine capsules and the specifics of their production.
Goals and objectives of the course in terms of The goals of the study course: to provide basic knowledge about the main principles of design and
competences and skills development of various drug dosage forms in pharmaceutical industry, the role and application of
various excipients in the development of dosage forms, quality assessment of dosage forms,
application of biopharmaceutical research in vitro in development of dosage forms.
The objectives of the study course: to provide competence in the basic principles of development
and manufacturing of various drug dosage forms, knowledge of good manufacturing practice in
pharmaceutical production, to develop abilities and skills to choose the most appropriate dosage
forms depending on active pharmaceutical ingredient and drug pathway.
Structure and tasks of independent studies Preparation for three tests (solid dosage forms, dosage forms for parenteral administration dosage
forms for parenteral administration, semisolid dosage forms).
Recommended literature Obligātā/Obligatory:
1. European Pharmacopoeia 6.0 vol.1, vol.2., Supplements 6.1., 6.2., 6.3., 6.4., 6.5., 6.6., 6.7., 6.8.
2. European Pharmacopoeia 7.0 vol.1, vol.2. Supplements 7.1. – 7.4.
3. USP - U. S. Pharmacopoeia 23, 1995.
4. British Pharmacopoeia 1993, vol. I, II.
5. DAB 10 - Deutsches Arzneibuch 10, 1994. Band 1 – 4.
6. Homöopathisches Arzneibuch 5 Nachtrag 1991.
Papildu/Additional:
7. Analysis of drug impurities / ed. by R.J.Smith, M.L.Webb. Oxford; Ames, Iow: Blackwell,
2007.
8. Nanomedicine for drug delivery and therapeutics / ed. by Ajay Kumar Mishra. Beverly, MA:
Scrivener Publishing, Wiley, 2013.
9. M.J.Groves. Parenteral Technology manual. USA, 1989.
10. Sterile Pharmaceutical Manufacturing. Ed. by M.J.Groves, W.P.Olson, M.H.Anisfeld. Vol. 1.
– 2., 1990, USA.
11. Pharmaceutical salts and co-crystals / ed. by J.Wouters, L.Quéré. Cambridge, UK: RSC
Publishing, 2012.
12. Liebermann H.A., Lachman L., Schwartz J.B. Pharmaceutical dosage forms, Tablets. Vol. 1,
Vol. 2, Vol. 3. New York. Mardel Dekker Inc. 1992.
13. Handbook of Pharmaceutical Exipients. 4th Edition. Ed. by R.C.Rowe, P.J.Sheskey,
P.J.Weller., 2003.
14. Pharmaceutics. The science of dosage form design. Ed.by M.E.Aulton, 2002.
15. Pharmaceutical capsules. Ed. by Fr.Podezeck, B.E.Jones, 2004.
16. Encyclopedia of Pharmaceutical technology. 3rd ed., 6 Volume Set.
17. Fiedler Encyclopedia of Excipients for Pharmaceuticals, Cosmetics and Related Areas. 6th ed.
Ed. E.M. Hoepfner, S.Lang, A.Reng, P.C.Schmidt. Vol. 1, Vol. 2, 2007.
18. Allen, Loyd V. Ansel's pharmaceutical dosage forms and drug delivery systems / Loyd V.
Allen, Jr., Howard C. Ansel, PhD. Philadelphia : Wolters Kluwer Health, 2014.
20. Pharmaceutical dosage forms and drug delivery / Ram I. Mahato, Ajit S. Narang. Boca Raton,
FL: CRC Press, 2012.
21. Essentials of pharmaceutical chemistry / ed. by D.Cairns. London; Chicago: Pharmaceutical
Press, 2012.
22. Zāļu un uztura mijiedarbība un blaknes / A.Skutelis, I.Bārene. Rīga: Medicīnas apgāds, 2013.
Course prerequisites Knowledge of organic synthesis and biological chemistry.
Course contents
Content Full- and part-time Part time extramural
intramural studies studies
Contact Indep. Contact Indep.
Hours work Hours work
Dosage forms. Obtaining, investigation of physical, chemical, pharmacologycal and toxicologycal 2 2 0 0
properties of active substances. Excipients. Composition of dosage forms. Packing materials
Assessment of quality of dosage forms. European Pharmacopoeia. Regulations. Validation of 2 2 0 0
methods of analyses. Studies of stability, shelf-life
Good manufacturing practice (GMP) and it importance for manufacturing of qualitative medicine. 2 2 0 0
GMP for starting materials
Solid dosage forms. Technology and standartization of powders. Preparing and quality assessment 2 2 0 0
of granules
The characterization of quality of tablets, assortment of excipients. The process of manufacturing of 2 2 0 0
tablets. Coating
Capsules - types and characterization. Manufacturing methods of gelatine capsules. Filling the 2 2 0 0
powders, oils and other solutions in the gelatine capsules
Aerosols. The characterization and classification of aerosols. The characterization of containers for 2 2 0 0
aerosols and propellants; technology and assessment of quality
Dispersion systems. Emulsions and suspensions. Assortment of surfactants (emulsifying agents). 2 2 0 0
Manufacturing and standardization of emulsions and suspensions
Soft dosage forms. The characterization and assortment of excipients of ointments, creams, gels, 2 2 0 0
pastes. Technology and assessment of quality of ointments, creams, gels and pastes
The characterization of the rectal and vaginal drugs. Excipients and vehicles (suppository bases) 1 2 0 0
The classification and assortment of plasters. The characterization of excipients is used in plasters 1 2 0 0
technology. Technology and assessment of quality of plasters
Solutions and liquids. The characterization of solvents used for preparation of solutions. Water 2 2 0 0
purification. Technology of preparation and quality assessment of water and non-aqueous solutions
Parenteral preparations and their quality requirements. Glass and plastic containers for parenteral 2 2 0 0
preparations. Organic and other solvents used for preparation of injection solutions.
The process of technology of parenteral preparations and assessment of their quality. Methods of 2 2 0 0
sterilization. Dosage forms for treatment of eye diseases
Biopharmaceutics. The mechanism of drug absorption. The factors influencing the dissolution 1 2 0 0
process and absorption of active substances. Methods of bioavailability assessment.
Interaction of food and drugs. The food influence on the bioavailability of drugs – (dissolution, 1 2 0 0
absorption, transport and excretion).
Test Nr. 1: Solid drug dosage forms. 1 4 0 0
Test Nr. 2: Parenteral drugs. 1 4 0 0
Test Nr. 3: Soft drug dosage forms. 1 4 0 0
Final test. 1 4 0 0
Total: 32 48 0 0
Learning outcomes and assessment
Learning outcomes Assessment methods
Is familiar with the legislation of pharmaceutical production and the registration of drug dosage Form of examination: tests; final test.
forms. Criteria: the student knows and understands
the legal requirements to be fulfilled in the
pharmaceutical production of drug dosage
forms, knows the course, requirements and
terminology of registration of drug dosage
forms.
Knows the advantages and disadvantages of different dosage forms of drugs, the main principles of Form of examination: tests; final test.
their selection depending on the specific API and the way they are administered. Criteria: the student is able to choose the most
appropriate dosage form of the drug
depending on the method of its
administration.
Knows the technologies of production of various drug dosage forms and quality control, is able to Form of examination: tests; final test.
communicate with other production specialists: pharmacists, technologists and analysts. Criteria: the student knows and is able to
choose the most appropriate technologies and
quality control methods for the production of
dosage forms, is able to solve specific
production problems.
Is able to choose a ready-made and optimal form of the drug. Form of examination: tests; final test.
Criteria: the student is able to solve the given
task by choosing the most optimal drug
dosage form for a particular pharmaceutical
product.
Evaluation criteria of study results
Criterion %
Test Nr. 1: Solid drug dosage forms 25
Test Nr. 2: Parenteral drugs 25
Test Nr. 3: Soft drug dosage forms 25
Final test 25
Total: 100
Study subject structure
Part CP Hours per Week Tests Tests (free choice)
Lectures Practical Lab. Test Exam Work Test Exam Work
1. 2.0 2.0 0.0 0.0 * *
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